By Fineline Cube 
Amoytop Biotech Co. Ltd. (SHA: 688278) announced today that the National Medical Products Administration (NMPA) has approved a new indication for its flagship product Pegbinterferon (PGB) in combination with nucleos(t)ide analogues (NAs) for the durable clearance of hepatitis B surface antigen (HBsAg) in adult patients with chronic hepatitis B (CHB).
Product & Regulatory Milestones
- Pegbinterferon (PGB) – the world’s first 40 kDa, long‑acting, polyethylene glycol‑modified interferon‑α‑2b injection, classified as a National Class I New Biological Product.
- Historical Approvals
- Chronic Hepatitis C – market launch in October 2016.
- Chronic Hepatitis B – initial approval for adult patients in September 2017.
- New Indication – NMPA approval for PGB + NA combination therapy to achieve durable HBsAg clearance, a critical milestone for functional cure strategies.
Clinical Significance
- Durable HBsAg Clearance – The new indication targets a key therapeutic endpoint, potentially transforming long‑term outcomes for the ~250 million people worldwide affected by CHB.
- Combination Synergy – Pairing Pegbinterferon with nucleos(t)ide analogues leverages complementary mechanisms of action, enhancing antiviral efficacy while mitigating resistance.
- Market Impact – As the first domestically developed PEG‑interferon product in China, Amoytop’s expanded indication positions it as a leader in the rapidly growing CHB therapeutic landscape.
Strategic Implications
- Portfolio Expansion – The NMPA approval strengthens Amoytop’s product line, providing a differentiated long‑acting interferon option for both hepatitis C and B indications.
- Commercial Advantage – The expanded indication will broaden the patient base and provide a rationale for higher utilization of Pegbinterferon in routine clinical practice.
- Future Outlook – Amoytop plans to pursue additional indications and global regulatory approvals, leveraging its robust clinical data and manufacturing capabilities.
About Amoytop Biotech
Amoytop Biotech Co. Ltd. is a leading Xiamen‑based biotechnology company focused on the discovery, development, and commercialization of innovative biopharmaceuticals. The company’s product portfolio includes PEG‑modified interferons and other antiviral agents, with a strong emphasis on hepatitis therapeutics.-Fineline Info & Tech